Associate Director, Safety Scientist

Job Description

• This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Safety Scientist based in Brazil. This is a senior pharmacovigilance role focused on safety science activities across early- and late-stage clinical development. You will lead the identification, assessment, and monitoring of potential safety signals across complex data sources. The role combines scientific analysis, risk management, regulatory support, and cross-functional leadership within a global matrix environment. You will partner closely with Safety Physicians, clinical teams, scientists, regulatory stakeholders, and other experts to evaluate emerging risks. Your work will directly contribute to patient safety, benefit-risk assessments, regulatory decision-making, and the safe development of innovative therapies. The position offers significant visibility across safety governance forums and opportunities to influence safety strategy and communication. It is ideal for an experienced pharmacovigilance professional with strong analytical judgment, scientific expertise, and excellent communication skills.
• Accountabilities: Lead the identification, analysis, evaluation, and documentation of safety signals using multiple internal and external data sources. Develop and lead appropriate data acquisition strategies, analytical methodologies, and approaches for safety evaluations. Analyze aggregate safety data and author comprehensive safety assessment reports, applying sound scientific judgment to identify potential risks and their implications. Collaborate with Safety Physicians, Product Safety Physician Leads, scientists, pharmacoepidemiologists, and other cross-functional experts to conduct thorough safety assessments. Lead the preparation and presentation of safety data for Safety Management Teams, Company Safety Committees, Safety Monitoring Committees, Data Monitoring Committees, and Data and Safety Monitoring Boards. Facilitate safety team meetings and communicate relevant safety information clearly and promptly to core teams, business partners, and key stakeholders. Lead the development, review, and maintenance of safety communication materials, including investigator communications, informed consent documents, Investigator’s Brochures, healthcare professional communications, labeling documents, and Risk Management Plans. Ensure signal detection and assessment activities are performed according to applicable regulations, established processes, and quality standards. Lead safety monitoring activities for assigned clinical trials and provide scientific expertise in the evaluation of patient safety data. Author and review safety sections of clinical and study documents, including protocols, Investigator’s Brochures, informed consent forms, statistical analysis plans, data displays, medical monitoring plans, and clinical study reports. Provide safety expertise for regulatory submissions, including IND/CTA and NDA/MAA-related materials, working closely with Safety Physicians and cross-functional study teams. Lead the preparation of storyboards, briefing books, and other materials supporting health authority interactions. Develop and maintain Safety Management Plans and lead Safety Science-specific investigator training activities. Analyze safety data and author relevant sections of regulatory inquiries and periodic safety reports, including DSURs and other applicable pharmacovigilance reports. Contribute to benefit-risk assessments, regulatory activities, safety risk management, and the continuous advancement of pharmacovigilance practices. Apply sound judgment and scientific reasoning to key clinical and safety discussions, while communicating complex issues effectively to diverse audiences. Requirements: PharmD or PhD in a medical field or biological science with 4+ years of experience in an analytical pharmacovigilance role. Alternatively, an RN with 8+ years of experience in an analytical pharmacovigilance role. Alternatively, an MD or internationally recognized equivalent, with accredited residency or comparable postgraduate clinical training, relevant clinical experience, and significant knowledge of general medicine. For physician candidates, experience in a relevant therapeutic area and at least 2 years of pharmaceutical or biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred. Strong practical knowledge of pharmacovigilance, safety signal detection, safety assessment, and risk management. Demonstrated experience analyzing clinical and safety data and translating findings into scientifically sound recommendations. Strong knowledge of applicable pharmacovigilance regulations, ICH standards, and clinical safety requirements. Advanced knowledge of MedDRA and experience working with safety databases to retrieve and evaluate safety information. Familiarity with data-mining and exploratory analysis tools such as Spotfire. Advanced proficiency with Microsoft Excel, PowerPoint, and Word. Strong scientific writing and presentation capabilities, with the ability to communicate complex safety information clearly and concisely. Ability to collaborate effectively within matrix organizations and influence cross-functional stakeholders without direct authority. Strong judgment, analytical thinking, attention to detail, and decision-making skills. Ability to lead safety discussions, facilitate meetings, and confidently present findings to senior stakeholders and governance committees. Fluent English is required. Willingness to travel occasionally, with expected travel of less than 10%. Benefits: Fully remote work opportunity from Brazil. Full-time position within a global, cross-functional pharmacovigilance environment. Opportunity to contribute to safety science activities spanning Phase I through Phase III clinical development. High visibility through participation in safety governance forums, regulatory activities, and cross-functional decision-making. Opportunities to collaborate with international Safety, Clinical Development, Regulatory, Medical, and scientific teams. Professional growth through exposure to complex safety assessments, emerging pharmacovigilance practices, and global regulatory activities. Opportunity to contribute directly to patient safety and benefit-risk decision-making for innovative therapies. The original job posting does not specify salary, healthcare coverage, bonus structure, or additional benefits; these details should be confirmed during the hiring process.
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